Completed Research Project

Developing an EORTC quality of life module for proctitis

Investigators: Spry N, Aoun S, Halkett GKB.

Funding: Edith Cowan University Industry Collaborative Scheme and Sir Charles Gairdner Hospital  ($60,000)

Administering institution: Edith Cowan University

The aim of this research is to develop a questionnaire module to assess the health-related quality of life of patients with proctitis, and the impact of treatment on patients’ lives. Proctitis is a condition arising from cancer treatment as a consequence of radiation to the pelvis and can have profound social and psychological consequences for patients and their family. This research provides the opportunities to work with an international group of scholars (EORTC Quality of Life Group) and contribute to the international body of literature on quality of life measures that will be used in cancer clinical trials.

The project consists of four phases:

  • Generating Quality of Life (QoL) issues by conducting semi-structured interviews with health care providers and affected patients
  • Operationalisation of the QoL issues into a set of items
  • Pre-testing of the module with patients in Australia and internationally
  • International field testing of the module so that it can be used in Clinical Trials

Results to date: During phase 1 of the study a list of 38 potentially relevant Quality of Life issues was developed and then compiled into the following seven categories: Incontinence (Flatus, Mucous, Solids, Liquids, Nocturnal); Pain (Abdominal bloating, pain and cramps, anal pain, rectal pain); Bleeding (per rectum – fresh or dark clots); Social Function (Limits social engagements as fear incontinence and needs to stay close to toilet); Role and Performance (Limits daily activity as fear incontinence and need to stay close to toilet, difficulty bending due to bowel problem, avoid certain foods); Fatigue (Reduction in energy due to bowel problem) and Emotional Function (Feeling anxious, frustrated, unattractive, embarrassed).  Interviews were conducted with seven health care providers and 10 patients to determine the relevance of each item and which items should be included in the module.

During phase 2 the items selected were compared with the EORTC item bank to determine which items should be included as questions in the proctitis module. Twenty five questions were developed to be tested with a sample of patients.

Phase 3 was divided into two stages. During stage 1 ten patients and five health professionals were interviewed and asked to complete the questionnaire. Analysis of this data identified that 9 questions needed to be rephrased and two questions needed to be deleted. The revised questionnaire was then further tested with 18 patients and data analysis showed that the questionnaire required no further changes.

The questionnaire has now been translated and pilot tested in the following languages Norwegian (n=15), German (n=15), Italian (n=20) and French (n=11). Following analysis of the data, the survey was amended and has now been approved by the EORTC. Additional funding has been obtained from the EORTC to commence large scale field testing (phase 4) in these countries.